Trial Outcomes & Findings for Self-Control and Adult Cigarette Smokers (NCT NCT02663882)

Last Updated: 2020-12-14

Results Overview

Participants were instructed to squeeze a hand-grip exerciser as long as possible and research staff used a stopwatch to time the length of time that the hand-grip is squeezed. A wad of paper was inserted between the handles of the hand-grip and timing stopped when the paper fell from the hand-grip indicating that the participant had released the hand-grip. The hand-grip was held before and after a thought suppression exercise that was meant to diminish self-control in order to control for individual hand strength. Self-control was measured as the difference in the length of time holding the hand-grip before and after the thought suppression exercise at each appointment (baseline and one week followup). Change in self-control due to task practice was measured as \[self-control at the second study appointment one week after the first appointment\] minus \[self-control at the first study appointment\].

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

Baseline, one week followup after baseline

Results posted on

2020-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Smoking-related Self Control Task self control practice - smoking related task self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day	Non-smoking-related Self Control Task self control practice - non-smoking related task self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day
Overall Study STARTED	39	36
Overall Study COMPLETED	35	34
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Smoking-related Self Control Task self control practice - smoking related task self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day	Non-smoking-related Self Control Task self control practice - non-smoking related task self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

Self-Control and Adult Cigarette Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smoking-related Self Control Task n=39 Participants self control practice - smoking related task self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day	Non-smoking-related Self Control Task n=36 Participants self control practice - non-smoking related task self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day	Total n=75 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 10.1 • n=5 Participants	46.8 years STANDARD_DEVIATION 11.3 • n=7 Participants	44.8 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, one week followup after baseline

Outcome measures

Outcome measures
Measure	Smoking-related Self Control Task n=35 Participants self control practice - smoking related task self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day	Non-smoking-related Self Control Task n=34 Participants self control practice - non-smoking related task self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day
Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline) data from baseline appointment	-9.36 seconds Standard Deviation 103.42	2.76 seconds Standard Deviation 80.82
Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline) data from second appointment, one week after baseline	-4.32 seconds Standard Deviation 109.14	42.88 seconds Standard Deviation 179.95

SECONDARY outcome

Timeframe: 2 assessments of this item over one week (baseline appointment, follow up appointment 1 week after baseline)

Self-control was measured using the investigator-developed Overall Self Control question (1 item): Participants were asked: How would you rate your overall level of self-control on a scale from 0 (I have no self-control) to 10 (I have complete self-control)? The response scale was a 10-point Likert scale ranging from 0 (I have no self-control) to 10 (I have complete self control). Higher scores indicated higher self control.

Outcome measures

Outcome measures
Measure	Smoking-related Self Control Task n=35 Participants self control practice - smoking related task self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day	Non-smoking-related Self Control Task n=34 Participants self control practice - non-smoking related task self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day
Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up baseline	6.1 score on a scale Standard Deviation 2.4	6.3 score on a scale Standard Deviation 4.5
Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up followup	6.5 score on a scale Standard Deviation 2.1	6.9 score on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: Baseline, follow up appointment one week after baseline

Change in self-reported average number of cigarettes smoked per day from study appointment 1 (baseline) to study appointment 2 (one week later). There is no official title to this item (cigarettes per day). Participants were asked to respond to this investigator-written question: "How many cigarettes each day do you smoke right now?" The response scale was open ("I smoke \_\_\_\_\_\_\_\_ cigarettes each day that I smoke") so that participants could write in any number of cigarettes. At baseline, there was no official minimum value but participants had to report smoking 10 cigarettes a day as part of the inclusion criteria for the study. There was no maximum response option provided. For the followup assessment (one week after baseline), participants were asked the same questions and there was no minimum or maximum response options provided. Higher numbers indicate a greater number of cigarettes smoked each day

Outcome measures

Outcome measures
Measure	Smoking-related Self Control Task n=35 Participants self control practice - smoking related task self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day	Non-smoking-related Self Control Task n=34 Participants self control practice - non-smoking related task self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day
Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up baseline	13.1 cigarettes per day Standard Deviation 4.1	12.0 cigarettes per day Standard Deviation 5.7
Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up followup appointment one week after baseline	12.0 cigarettes per day Standard Deviation 5.7	13.2 cigarettes per day Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline, follow up one week after baseline

Change in a biochemical measure of smoking (expired breath carbon monoxide level) from study appointment 1 (baseline) to study appointment 2 (one week later) This measure is not a scale. Participants provide a breath sample into a carbon monoxide monitor and the monitor provides a number from 0 and up in ppm (parts per million). Higher numbers indicate greater levels of carbon monoxide and this level is used as a proxy for amount of recent smoking (higher numbers indicating greater recent smoking).

Outcome measures

Outcome measures
Measure	Smoking-related Self Control Task n=35 Participants self control practice - smoking related task self control practice - smoking related task: participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day	Non-smoking-related Self Control Task n=34 Participants self control practice - non-smoking related task self control practice - non-smoking related task: participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day
Change in Expired Breath Carbon Monoxide Level baseline	18.4 ppm (parts per million) Standard Deviation 6.4	16.6 ppm (parts per million) Standard Deviation 6.6
Change in Expired Breath Carbon Monoxide Level followup (one week after baseline)	16.8 ppm (parts per million) Standard Deviation 10.4	16.8 ppm (parts per million) Standard Deviation 5.5

Adverse Events

Smoking-related Self Control Task

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-smoking-related Self Control Task

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrea Weinberger

Yeshiva University

Phone: (646) 592-4474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place